MALE NATURAL RUBBER LATEX CONDOM
Device Facts
| Record ID | K010919 |
|---|---|
| Device Name | MALE NATURAL RUBBER LATEX CONDOM |
| Applicant | Innolatex Sdn. Bhd |
| Product Code | HIS · Obstetrics/Gynecology |
| Decision Date | Jun 15, 2001 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.
Special Controls
*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
